2. What should I know before I take TINASIL?
Do not take if you have ever had an allergic reaction to TINASIL or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with TINASIL and affect how it works.
4. How do I take TINASIL?
Your doctor will advise you on the appropriate dose.
For skin infections: take 250 mg TINASIL once a day.
For fungal infection of finger and toenails: take 250 mg TINASIL once a day.
If your fungal infection does not improve, your doctor will review and determine if
an alternative antifungal therapy is needed.
5. What should I know while taking TINASIL?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are taking TINASIL.
Tell your doctor immediately if you develop any signs of an allergic reaction.
|
|
Things you should not do
|
Do not stop taking this medicine suddenly.
Do not use TINASIL in children.
|
|
Driving or using machines
|
TINASIL may cause dizziness in some people. Avoid driving vehicles or using machines
if you are dizzy.
Be careful before you drive or use any machines or tools until you know how TINASIL
affects you.
|
|
Looking after your medicine
|
Store below 25°C.
Keep your tablets in the original container until it is time to take them.
|
6. Are there any side effects?
Common side effects include low appetite, headache, dizziness, weakness, vomiting,
rash, hives, feeling sick, yellowing of the skin and eyes, light-coloured stools,
dark coloured urine, indigestion.
Active ingredient(s):
Terbinafine hydrochloride
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking TINASIL. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking TINASIL.
Where to find information in this leaflet:
1. Why am I taking TINASIL?
TINASIL contains the active ingredient Terbinafine hydrochloride. TINASIL belongs to a group of medications called antifungals.
TINASIL tablets are used to treat:
fungal infections of fingernails and toenails (Onychomycosis)
tinea (ringworm) infections of the groin and body
tinea infections of the feet, commonly called "athlete's foot"
These infections are caused by a group of fungi called dermatophytes.
Terbinafine, the active ingredient in TINASIL tablets, works by killing the dermatophytes.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you.
Your doctor may have prescribed it for another reason.
2. What should I know before I take TINASIL?
Warnings
Do not take TINASIL if:
you have ever had an allergic reaction to:
terbinafine, the active ingredient, or to any of the other ingredients listed at the
end of this leaflet.
any other medicines, foods, preservatives or dyes.
Your doctor will want to know if you are prone to allergies.
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
you have or ever had a problem with your kidneys or liver
TINASIL is not recommended if you currently have a liver problem because it may make
the problem worse. If you had a liver problem in the past and your liver is functioning
normally now, your doctor may prescribe TINASIL tablets but may want to check your
liver function before and during treatment with this medicine. Your doctor might take
blood tests to monitor your liver function. In case of abnormal test results they
may ask you to stop taking TINASIL.
the expiry date printed on the pack has passed or if the packaging is torn or shows
signs of tampering
Check with your doctor if you:
are pregnant or plan to become pregnant
are breastfeeding
if you have other medical conditions including if you have liver problems or any symptoms
such as feeling sick, loss of appetite, weakness, vomiting, pain in the right upper
park of tummy or yellowing of skin or eyes, dark urine or pale stools
have any skin problems such as rash, red skin, blistering of the lips, eyes or mouth,
skin peeling, fever (possible signs of serious skin reactions), rash due to high level
of a specific type of white blood cells (eosinophilia), serious skin reactions (such
as Stevens-Johnson syndrome, a serious disorder of the skin with symptoms such as
blisters, weakness, fever or toxic epidermal necrolysis)
have or experience thickened patches of red/silver skin (psoriasis) or facial rash,
joint pain, muscle disorder, fever (cutaneous and systemic lupus erythematosus).
have any blood disorders or experience weakness, unusual bleeding, bruising or frequent
infections
If you are not sure whether you should start taking TINASIL tablets, talk to your
doctor or pharmacist.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
TINASIL is not recommended during pregnancy. Your doctor will advise you regarding
the possible risks and benefits of using TINASIL during pregnancy. There is no experience
with use of TINASIL tablets during pregnancy. If your doctor thinks it is necessary
for you to take it, he/she will discuss with you the benefits and risks involved.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Do not use TINASIL during breastfeeding as terbinafine hydrochloride passes in breast
milk. There is a possibility that your baby could be affected.
Laboratory tests
Your doctor might do routine blood tests, liver function test before and during TINASIL.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with TINASIL and affect how it works.
Tell your do doctor or pharmacist if you take any of the following:
warfarin, a drug used to prevent blood clots
oral contraceptives (birth control pills). You may have problems, such as bleeding
between periods, while you are taking TINASIL tablets.
some medicines used to treat an irregular heartbeat, heart problems, high blood pressure
and migraines (e.g. metoprolol)
caffeine
drugs used to treat depression and other mental problems (e.g. tricyclic antidepressants:
desipramine, selective serotonin reuptake inhibitors (SSRIs), antiarrhythmics Class
1A, 1B, and 1C, and monoamine oxidase inhibitors (MAOIs) Type B)
cyclosporin, a medicine used to prevent organ transplant rejection or treat certain
problems with the immune system
drugs used for treatment of cough e.g. dextromethorphan
some medicines for Parkinson's disease
Medicines that may
increase
the effect of TINASIL include:
cimetidine or other similar medicines used to treat stomach ulcers
other antifungal medicines such as Fluconazole, ketoconazole
Medicines that may
reduce
the effect of TINASIL include:
rifampicin or other similar antibiotics used to treat infections.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect TINASIL.
4. How do I take TINASIL?
How much to take
Follow your doctor's instructions on how many TINASIL tablets to take.
The usual dose of TINASIL is one tablet (250 mg) each day. If you have kidney problems,
the dose may be reduced to one-half a tablet each day.
When to take TINASIL
Take TINASIL at about the same time each day.
Taking your tablet at the same time each day will have the best effect. It will also
help you remember when to take it.
How to take TINASIL
Swallow the tablet with a full glass of water.
If your doctor has advised that you take half a tablet, you may divide the tablet
in half along the breakline.
If you find that TINASIL upsets your stomach, try taking it immediately after a light
meal.
How long to take it
The length of your treatment will depend on the type of infection you have, what part
of the body is affected and how well you respond to treatment. Your doctor will advise
you regarding the duration of treatment.
Fungal skin infections (tinea):
If you have a tinea infection of the feet (Athlete's foot), you will usually take
TINASIL tablets for 2 to 6 weeks.
If you have a tinea infection of the body or groin, you will usually take the tablets
for 2 to 4 weeks.
The signs and symptoms of infection may last for several weeks after the fungi (dermatophytes)
have been killed.
Fungal nail infections:
Fungal nail infections usually take longer to heal than fungal skin infections. You
will usually take the tablets for anywhere from 6 weeks to 3 months. But, if you have
a nail infection of the big toe or your nails grow very slowly, you may need to take
the tablets for up to 6 months.
It may take several months after you stop taking TINASIL for your nail to look completely
normal. That is because the deformed part of the nail has to grow out and be replaced
by a healthy nail.
If your fungal infection does not improve. Your doctor will review and determine if
an alternative antifungal therapy is needed.
If you forget to take TINASIL
If it is almost time for your next dose (within 4 hours), skip the dose you missed
and take your next dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking your medicine
as you would normally.
Do not take a double dose to make up for the dose you missed.
This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask your pharmacist for
some hints.
If you take too much TINASIL
If you think that you or anyone else has taken too much TINASIL, urgent medical attention
may be needed.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
Some of the symptoms of an overdose may include headache, nausea (feeling sick), stomach
pain and dizziness.
5. What should I know while taking TINASIL?
Things you should do
Make sure to take your tablet every day and continue taking it until your doctor tells
you to stop.
This will ensure that all of the infection is gone and will lessen the chance of the
infection coming back once you stop taking the tablets.
Make sure to have any blood tests done that are ordered by your doctor.
Any effects of TINASIL on your liver, kidneys or blood can be detected by blood tests.
Keep the infected areas dry and cool and change clothing which is in direct contact
with the infected areas every day.
Call your doctor straight away if you notice any of the following:
any signs of an allergic reaction
fever
sore throat
mouth ulcers
"flu-like" symptoms (chills, aching joints, swollen glands, lack of energy)
any other signs of infection, apart from the fungal infection you are being treated
for
become pregnant
Remind your doctor and pharmacist that you are about to be started on any new medicine.
Remind any doctor, dentist or pharmacist you visit that you are taking TINASIL.
Things you should not do
Do not stop using this medicine suddenly.
Do not use TINASIL in children.
Do not give TINASIL to anyone else, even if they have the same condition as you.
Do not take TINASIL tablets to treat any other complaints unless your doctor tells
you to.
Driving or using machines
Be careful before you drive or operate any machines or tools until you know how TINASIL
affects you.
TINASIL may cause dizziness, tiredness, sleepiness or light-headedness in some people.
If you have any of these symptoms, do not drive, use machines, or do anything else
that could be dangerous.
Looking after your medicine
Keep your tablets in the original container until it is time to take them.
Store below 25°C.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep it where young children cannot reach it.
A locked cupboard at least one-and a-half metres above the ground is a good place
to store medicines.
Getting rid of any unwanted medicine
If you no longer need to take this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not take this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What TINASIL contains
|
Active ingredient
(main ingredient)
|
Terbinafine (as the hydrochloride salt) 250 mg
|
|
Other ingredients
(inactive ingredients)
|
microcrystalline cellulose
croscarmellose sodium
povidone
colloidal anhydrous silica-
purified talc
magnesium stearate
|
Do not take this medicine if you are allergic to any of these ingredients.
What TINASIL looks like
TINASIL tablets are round, white to off-white tablets marked with "TF" over a breakline
over "250" on one side and "G" on the other side (AUST R 104493).
TINASIL tablets are supplied in blister packs containing 42 tablets.
Who distributes TINASIL
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in December 2025.
TINASIL® is a Viatris company trade mark
TINASIL_cmi\Dec25/00